MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA POSTERIOR VITRECTOMY PACK WITH VALVES AND WIDE FIELD ILLUMINATOR; UNIT, PHACOFRAGMENTATION

Model Number	BL5223WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in china reported the vitrectomy cutter did not cut when the doctor began to perform the operation.Aspiration continued while the cutter was not working.There was no impact to the patient.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
Although the product was not received for evaluation, a review of the video provided by the user facility was performed.The original packaging is not visible in the video.The part number and lot number cannot be verified or determined.However, the video does clearly show a 23ga vitrectomy cutter in a surgical setting.The tip of the vitrectomy cutter is in a priming cup.The tubing is fully assembled and appears to be correctly attached to the stellaris system, though it cannot be verified by viewing the video if all the tubing connections are tight.The cutter is activated with the cut rate set to 5000 cuts per minute.The cutter can be heard "humming", and the water surface agitation verifies that it is active.In addition, the system vacuum rate is set to 200 mmhg.The tubing has large air bubbles in the line and almost no flow can be seen moving through the aspiration line and no fluid can be seen dripping into the collection cassette.The cutter does not appear to be aspirating.The back cap and barbed connectors are not visible in the video.It is unknown if the aspiration barb is damaged.This cutter has an air leak.The source of the air leak cannot be determined by viewing the video alone.No further evaluation can be performed as the vitrectomy cutter was not received.While the video indicates that the cutter is not aspirating, the root cause could not be determined since the part had not been returned for analysis.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Additional Manufacturer Narrative
The product evaluation has been completed.One opened bl5223wv pack from lot x6065r was returned.The expiration date on the label is 2025-sep-23.Visual inspection found the collection cassette assembly is dirty with dried solution visible throughout the tubing.However, the collection cassette is clean and dry.The 23ga vit cutter tubing is coiled and rubber band together.There are droplets of dried solution visible in the tubing.The tip protector was not returned.The needle is not bent.The port window is in the opened position.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected, and no defects noted.A functional test was performed using a stellaris pc system.The cutter had good clean cuts throughout the various cut rates and had good aspiration.This cutter performed as intended.It cannot be verified by viewing the video if all the tubing connections were tight, however, they are now.This complaint will be confirmed based on the video.The root cause could not be determined as the returned product performed as intended.No corrective action required.The investigation is complete.

• Brand Name: 23 GA POSTERIOR VITRECTOMY PACK WITH VALVES AND WIDE FIELD ILLUMINATOR
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 22530723
• Report Number: 0001920664-2025-00089
• Device Sequence Number: 15325463
• Product Code: HQC
• UDI-Device Identifier: 00757770058587
• UDI-Public: (01)00757770058587(17)250923(10)X6065R
• Combination Product (Y/N): N
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: BL5223WV
• Device Lot Number: X6065R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 10/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/12/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Sex: Unknown